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No new safety and tolerability signals were observed in this two-year extension study. Moreover, epratuzumab’s efficacy – measured by fall in disease activity – was maintained during the two year period. Secondary findings also pointed toward decreases in corticosteroid use in patients receiving >7.5 mg/day of epratuzumab for over two years.

The 12-week EMBLEM study had enrolled 227 patients with moderate-to-severe SLE to find an appropriate dosing regimen for epratuzumab by treating patients with either placebo or epratuzumab in various dosages. The phase IIb extension study was conducted to gain two-year open-label data.

Epratuzumab is in-licensed from Immunomedics Inc. (IMMU - Free Report) and is currently in a phase III program.

The SLE market currently has products like Benlysta and Plaquenil. Benlysta was approved in Mar 2011 by the US Food and Drug Administration (FDA) and is currently available in the US, Canada and a number of European and other countries. In addition, regulatory submissions are pending in other countries.

The SLE market is attracting a number of drug makers. Notable among these is Takeda Pharmaceutical, which collaborated with Resolve Therapeutics earlier this year for the development of treatments for SLE and other autoimmune diseases. Moreover, a large cap pharma company is developing tabalumab for SLE in a phase III study, ILLUMINATE.

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